ERC Annual Report Form - Philippine Health Research Ethics

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ERC Annual Report Form - Philippine Health Research Ethics
PHREB Form 002
Annual Report Form
Ver. 002 | Rev. 11 Feb 2015
ETHICS REVIEW COMMITTEE ANNUAL REPORT
January 20____ to December 20____
A. Information about the Ethics Review Committee (ERC)
Name of Ethics Review Committee:
Name of Institution:
Address:
(No.,
Street,
Town/City, Province, Region)
ERC Level of Accreditation
Report prepared by:
[ ] Level 1
[ ] Level 2
[ ] Level 3
Name of Chairperson:
Telephone:
Mobile:
Fax:
Email address:
Name of Contact Person:
Position:
Telephone:
Mobile:
Fax:
ERC Email
address:
B. Composition of Ethics Review Committee
Number of Members:
NAME
PROFESSION/
SPECIALTY/
OCCUPATION
Sex
M F
Affiliated
with the
Institution
YES NO
Ethics Training
YES, Please
indicate
(Basic, GCP,
SOP)
NO
Chair:
Vice-Chair:
Secretary:
Members:
Page 1 of 3
PHREB Form 002
Annual Report Form
Ver. 002 | Rev. 11 Feb 2015
NAME
PROFESSION/
SPECIALTY/
OCCUPATION
Sex
M F
Affiliated
with the
Institution
YES NO
Ethics Training
YES, Please
indicate
(Basic, GCP,
SOP)
NO
Members: (cont.)
*Add more rows if needed
(1) Change/s in the composition of the committee during the year, if any:
___________________________________________________________________________
C. Number of Protocols according to Type of Research from January 1, 20___ to December 31, 20___
(*Please attach PHREB Form 006 Protocol Summary)
Type of research
Clinical Trials (sponsor-initiated)
- Phase 1
-
Phase 2
-
Phase 3
-
Phase 4
Number of Protocols Reviewed
Clinical Trials (researcher-initiated)
Biomedical studies include Retrospective, Prospective
and Diagnostic Studies, and use of human material and
data
Health Operations Research includes studies on Health
Programs and Policies
Social Research includes KAPs of communities, behavioral
research, impact of Public Health interventions
Public Health Research includes epidemiologic researches
(prevalence, surveys, incidence)
Others (Please specify)
TOTAL NO. OF PROTOCOLS REVIEWED
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PHREB Form 002
Annual Report Form
Ver. 002 | Rev. 11 Feb 2015
D. Please indicate:
1.
2.
3.
4.
Problems/Issues Encountered
during ERC Operations
Functionality of structure and
composition
Adherence to international, national,
institutional guidelines and policies
Adequacy of standard operating
procedures and consistency of
implementation
Completeness of review process
Action/s taken by ERC
5. Adequacy of after review process
6. Adequacy of administrative support
7. Efficiency of the recording and
archiving system
8. Others
Submitted by:
Date of
Application:
________________________________
Signature over Printed Name
Noted by:
______________
MM/DD/YYYY
Date:
________________________________
Signature over Printed Name of ERC Chair
Endorsed by:
______________
MM/DD/YYYY
Date:
________________________________
Signature over Printed Name
of Head of Institution
______________
MM/DD/YYYY
Page 3 of 3

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